Description
This guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product that includes both a drug constituent part and a delivery device constituent part. The recommendations included in this guidance generally focus on the analysis of the proposed user interface for the generic drug-device combination product (generic combination product) when compared to the user interface for the reference listed drug (RLD). For the purposes of this guidance, the term user interface refers to all components of the combination product with which a user interacts. This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging.
Scope & Applicability
Product Classes
2Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
The guidance addresses approval of generic combination products under an ANDA.
Stakeholders
4It may be a hardship for patients and/or caregivers to attend in-person; Individuals who may assist patients or provide observations when patients cannot self-report.; conducted with caregivers to obtain similar feedback
Way questions are framed is critical to collecting unbiased patient input
Reference Listed Drug used for comparison in ANDAs
Prescribing professional who does not need to intervene for interchangeable substitution
Regulatory Context
Attributes
4Features that directly affect how users perform a critical task.
Requirement for selecting a generic drug as a reference standard
primary endpoint for a comparative use human factors study
attributes that involve administration of the product
Related CFR Sections (5)
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.127§ 314.127 Refusal to approve an ANDA.
(a) FDA will refuse to approve an ANDA for a new drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act for any of the following reasons, unless the requirement has been waived under § 314.99 :Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR314.93§ 314.93 Petition to request a change from a listed drug.
(a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →
Related Warning Letters (5)
- 2025-03-18
CGMP/Finished Pharmaceutical/Adulterated
Advanced Pharmaceutical Technology
- 2024-08-27
CGMP/Drugs/Adulterated
EyePoint Pharmaceuticals, Inc.
- 2024-08-06
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Omega Tech Labs LLC
- 2021-06-29
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Aquavit Pharmaceuticals, Inc
- 2020-07-21
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Centurion Medical Products Corporation
See Also (8)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff (Status: Final)
- Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA Staff (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
- New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry (Status: Final)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage: Guidance for Industry (Status: Final)
- Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff (Status: Draft)